Fontan Patients: Comprehensive Evaluation of Pulmonary Circulation and Ventricular Function
In patients with one anatomical or functional ventricular chamber, which encompasses a spectrum of rare and complex congenital cardiac malformations, a staged surgical approach in view of an ultimate Fontan operation has become the procedure of choice. Especially in the earlier era, perioperative mortality was the leading cause of death. However, many patients have a long and high-quality life, continuously improved by a better understanding of Fontan hemodynamics and the refinement of the surgical procedures. Nevertheless, the prospect of eventual failure of the Fontan circulation remains a major concern. More specifically, evaluation of the pulmonary circulation becomes particularly important as the failing Fontan circulation has become a common indication for cardiac transplantation. Although essential, especially in the preoperative setting, a comprehensive evaluation of the pulmonary circulation remains difficult in this patient population
Our global hypothesis is that the absence of pulsatile pulmonary flow may lead to the development of pulmonary vascular lesions after the Fontan operation and that - together the absence of a subpulmonary ventricle for pressure generation - this increasing afterload will result in systemic ventricular underfilling and will eventually lead to a failing Fontan circulation.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Fontan Patients: Comprehensive Evaluation of the Pulmonary Circulation to Identify Pulmonary Vascular Disease and Its Influence on Ventricular Hemodynamics.|
- Systemic ventricular stroke volume during exercise [ Time Frame: 30 minutes after administration of sildenafil ] [ Designated as safety issue: No ]Systemic ventricular stroke volume during exercise as evaluated using bicycle stress magnetic resonance imaging.
|Study Start Date:||April 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
All patients will be given Sildenafil 50 mg with evaluation of pulmonary vascular resistance and systemic ventricular function at rest and during exercise after 30 minutes.
50 mg once
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01572363
|University Hospitals Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Werner Budts, MD, PhD||University Hospitals Leuven|